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azatadine and pseudoephedrine

Generic Name: azatadine and pseudoephedrine (a ZA ta deen and soo doe e FED rin)
Brand Name: Trinalin Repetabs

What is azatadine and pseudoephedrine?

Azatadine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of azatadine and pseudoephedrine is used to treat sneezing, itching, watery eyes, runny nose, and nasal or sinus congestion that is caused by allergies or the common cold of flu.

Azatadine and pseudoephedrine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about azatadine and pseudoephedrine?

Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body.

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Avoid drinking alcohol while you are taking this medication. It can add to drowsiness caused by an antihistamine.

Do not use any other over-the-counter cold, allergy, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains an antihistamine or decongestant.

What should I discuss with my healthcare provider before taking azatadine and pseudoephedrine?

Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body.

Do not use this medication if you are allergic to azatadine, pseudoephedrine or to other antihistamines, decongestants, diet pills, stimulants, or ADHD medications.

Before taking azatadine and pseudoephedrine, tell your doctor if you are allergic to any drugs, or if you have:

  • heart disease or high blood pressure;

  • diabetes;

  • a thyroid disorder;

  • glaucoma;

  • kidney disease;

  • an enlarged prostate; or

  • problems with urination.

If you have any of these conditions, you may not be able to use this medication, or you may need a dosage adjustment or special tests during treatment.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

This medication may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take azatadine and pseudoephedrine?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label. Cold or allergy medicine is usually taken for only a short time until your symptoms clear up.

Take this medicine with food or milk if it upsets your stomach.

Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children.

Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time.

Do not take more of this medication than is recommended. Take a maximum of 1 tablet every 12 hours. An overdose of this medication can cause serious harm.

Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

This medication can cause you to have unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.

Store azatadine and pseudoephedrine at room temperature away from moisture and heat.

What happens if I miss a dose?

Since cold or allergy medicine is usually taken only as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of an azatadine and pseudoephedrine overdose include feeling restless or nervous, nausea, vomiting, stomach pain, dizziness, drowsiness, dry mouth, warmth or tingly feeling, or seizure (convulsions).

What should I avoid while taking azatadine and pseudoephedrine?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid drinking alcohol while you are taking this medication. Alcohol can add to drowsiness caused by an antihistamine.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Avoid using other medicines that make you sleepy (such as pain medication, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by azatadine.

Avoid becoming overheated or dehydrated during exercise and in hot weather.

Do not use any other over-the-counter cold, allergy, or sleep medication without first asking your doctor or pharmacist. Antihistamines and decongestants are contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains an antihistamine or decongestant.

Azatadine and pseudoephedrine side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • fast, pounding, or uneven heartbeat;

  • increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);

  • confusion, hallucinations, unusual thoughts or behavior;

  • severe dizziness, anxiety, restless feeling, or nervousness;

  • easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or

  • urinating less than usual or not at all.

Keep using the medication and talk with your doctor if you have any of these less serious side effects:

  • mild loss of appetite;

  • dry mouth;

  • nausea, stomach pain, constipation;

  • warmth, tingling, or redness under your skin;

  • sleep problems (insomnia);

  • skin rash or itching;

  • blurred vision;

  • dizziness, drowsiness;

  • problems with memory or concentration;

  • ringing in your ears; or

  • restless or excitability (especially in children).

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

See also: Side effects (in more detail)

Azatadine and pseudoephedrine dosing information

Usual Adult Dose for Allergic Rhinitis:

1 tablet (1 mg-120 mg) orally twice a day as needed.

Usual Adult Dose for Nasal Congestion:

1 tablet (1 mg-120 mg) orally twice a day as needed.

Usual Pediatric Dose for Allergic Rhinitis:

>12 years:

1 tablet (1 mg-120 mg) orally twice a day as needed.

Usual Pediatric Dose for Nasal Congestion:

>12 years:

1 tablet (1 mg-120 mg) orally twice a day as needed.

What other drugs will affect azatadine and pseudoephedrine?

Before taking this medication, tell your doctor if you are using any of the following drugs:

  • a diuretic (water pill);

  • medication to treat irritable bowel syndrome;

  • bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol) or tolterodine (Detrol);

  • aspirin or salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others);

  • medicines to treat high blood pressure;

  • a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others; or

  • antidepressants such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others.

If you are using any of these drugs, you may not be able to use azatadine and pseudoephedrine, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect azatadine and pseudoephedrine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist has information about azatadine and pseudoephedrine written for health professionals that you may read.

What does my medication look like?

Azatadine and pseudoephedrine is available with a prescription under the brand name Trinalin Repetabs. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

  • Trinalin Repetabs, 120 mg of pseudoephedrine and 1 mg of azatadine--coral-colored, round tablets

  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 4.04. Revision Date: 2007-04-14, 9:52:22 AM.

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